BEUDAMED
    FDA Adverse Event Summary report: N

    ADAPTA DR

    MDR report key: 1863169 · Received October 9, 2010

    Report

    Report Number
    6000094-2010-01928
    Date Received
    October 9, 2010
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    NVZ
    PMA / PMN Number
    P980035/S043
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. EVALUATION SUMMARY:(B)(4) NO ANOMALIES WERE FOUND. FURTHER TESTING REVEALED GROMMET DAMAGE; MICROSCOPE INSPECTION SHOWS THAT THE GROMMET HAS SUSTAINED DAMAGE.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING IMPLANT, THE DEVICE SHOWED OVERSENSING AND NOISE. THE PHYSICIAN RETRIEVED THE DEVICE AND FOUND BLOOD/BODY FLUID INGRESS. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADAPTA DR ASKU NVZ MEDTRONIC S.A. ADDRL1 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention